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NCT07728721
Evaluating the Efficacy and Safety of of HSK50042 in People With Idiopathic Pulmonary Fibrosis
Conditions: Idiopathic Pulmonary Fibrosis (IPF)
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 175
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Summary
This study is open to adults with idiopathic pulmonary fibrosis who are at least 40 years old. The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.
Eligibility Criteria
Inclusion Criteria:
1\. Diagnosed with Idiopathic Pulmonary Fibrosis (IPF) prior to screening, patients must meet both of the following criteria:
1. IPF based on 2022 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest HRCT scan taken before or during screening period and if available surgical lung biopsy.
2. Usual interstitial pneumonia (UIP) or probable UIP HRCT pattern consistent with the clinical diagnosis of IPF, as confirmed by the investigator prior to screening. if indeterminate HRCT finding IPF may be confirmed locally by (historical) biopsy.
2\. Percentage Predicted Forced Vital Capacity (ppFVC) ≥45% at screening period. 3. Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin \[Hb\]) ≥ 25% and\
Source: ClinicalTrials.gov (NCT07728721). StuddyBuddy aggregates publicly available trial information.